Clinical Investigator Information
Conducting A Clinical Investigation
- Clinical Trials and Institutional Review Boards
- Good Clinical Practice in FDA-Regulated Clinical Trials
- Information for Clinical Investigators (CDER)
- Investigational New Drug (IND) Guidances
- Information on Submitting an Investigational New Drug (IND) Application
- Manual of Regulatory Standard Operating Procedures and Policies
- Participation of Females in Clinical Trials and Gender Analysis of Data in Biologic Product Applications
- Letters to Industry / Healthcare Providers / Clinical Investigators
- Clinical Hold / Refusal to File Meetings
- Clinical Investigator Inspection List
- Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letters
National Institutes of Health (NIH) Resources